AESCULAP NX044Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 04046963810306), received between Oct 6, 2020 and Apr 4, 2025 — classified as 12 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (9 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryApr 4, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED TO AESCULAP INC. THAT A PATELLA 3-PEGS P4 (PART# NX044) WAS IMPLANTED ON (B)(6) 2019. ACCORDING TO THE EVENT DESCRIPTION, A SURGERY TO REPLACE THE POLYETHYLENE COMPONENT(S) HAD BEEN PLANNED FOR (B)(6) 2025. THE ADVERSE EVENT IS FILED UNDER AIC REFERENCE (B)(4). ASSOCIATED MEDWATCH REPORTS: 3005673311-2025-00032. 3005673311-2025-00034. 3005673311-2025-00035. 3005673311-2025-00036. 3005673311-2025-00037.

  Patient problems: Failure of Implant

  MAUDE report 21778294 ↗
• InjuryJan 19, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  INVESTIGATION COMPLETE.

  Patient problems: Failure of Implant

  MAUDE report 16207524 ↗
• InjuryJan 19, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED TO AESCULAP INC. THAT A PATELLA 3-PEGS P4 (ITEM NX044) WAS IMPLANTED DURING A LEFT TOTAL KNEE ARTHROPLASTY (TKA) ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, ASEPTIC LOOSENING OF AESCULAP VEGA CEMENTED TOTAL KNEE REPLACEMENT WITH-DE-BONDING OF THE IMPLANT FROM THE CEMENT MANTLE. THE PATIENT UNDERWENT A REVISION PROCEDURE PROCEDURE ON (B)(6) 2022. THE COMPLAINT DEVICE WAS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION SURGERY. THE ADVERSE EVENT/MALFUNCTION IS FILED UNDER AIC REFERENCE (B)(4). ASSOCIATE MEDWATCH REPORTS (B)(4) 2916714-2023-00006_MDR, (B)(4) 2916714-2023-00008_MDR, (B)(4) 2916714-2023-00009_MDR, (B)(4) 2916714-2023-00010_MDR.

  Patient problems: Failure of Implant

  MAUDE report 16206247 ↗
• InjuryApr 1, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH A KNEE IMPLANT SYSTEM. ACCORDING TO THE COMPLAINT DESCRIPTION THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PATIENT HAS EXPERIENCED PAIN, DIFFICULTY WALKING, AND LOOSENING OF THE IMPLANT. THE PRIMARY SURGERY OCCURRED ON (B)(6) 2013 AND THE REVISION SURGERY OCCURRED ON (B)(6)2018. A REVISION SURGERY WAS NECESSARY. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED AT THIS TIME, IF ADDITIONAL INFORMATION BECOMES AVAILABLE THE REPORT WILL BE UPDATED ACCORDINGLY. THE ADVERSE EVENT IS FILED UNDER (B)(4). INVOLVED COMPONENTS: NX132 - VEGA PS GLIDING SURFACE T3/3+ 14MM - LOT 51949663, NN260P - PLUG F/TIBIAL PLATEAU - LOT 51974495, NX013Z - AS VEGA PS FEMORAL COMP.CEMENTED F6N L - LOT 51927043, NX055Z (PS TIBIA CEMENTED T3); - LOT 51938561, NX044 - PATELLA 3-PEGS P4 - LOT51911583, CEMENT USED IS UNIDENTIFIED. ASSOCIATED MEDWATCHES: 2916714-2020-00307, 2916714-2020-00308, 2916714-2020-00309, 2916714-2020-00310, 2916714-2020-00311.

  Patient problems: Ambulation or Postural Difficulties; Implant Pain; Joint Laxity

  MAUDE report 11604313 ↗
• InjuryMar 4, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED TO AESCULAP INC. THAT A VEGA KNEE IMPLANT SYSTEM WAS IMPLANTED DURING A PRIMARY SURGERY PERFORMED ON (B)(6) 2013(LEFT) (B)(6) 2013(RIGHT). ACCORDING TO THE COMPLAINANT, FOLLOWING THE PRIMARY SURGERY, THE PATIENT EXPERIENCED PAIN SWELLING, DIFFICULTY WALKING AND LOOSENING OF THE IMPLANT, WHICH RESULTED IN A LEFT KNEE REVISION SURGERY. THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2015 LEFT KNEE. THE COMPLAINT DEVICE WAS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED AT THIS TIME, IF ADDITIONAL INFORMATION BECOMES AVAILABLE THE COMPLAINT WILL BE UPDATED ACCORDINGLY. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER REFERENCE (B)(4). INVOLVED COMPONENTS: NX013Z (PS FEMUR CEMENTED F6N LT), NX055Z (PS TIBIA CEMENTED T3), NN260P (PEEK PLUG F/ TIBIA), NX044 (UNIVERSAL PATELLA P4), NX130 (PS PE INSERT T3/T3+, 10MM). ASSOCIATED MEDWATCHES: 2916714-2020-00355, 2916714-2020-00356, 2916714-2020-00357, 2916714-2020-00359.

  Patient problems: Ambulation or Postural Difficulties; Implant Pain; Joint Laxity; Swelling/ Edema

  MAUDE report 11416170 ↗
• InjuryJan 5, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH AS VEGA KNEE, RIGHT SIDE. IT WAS REPORTED THAT AS A RESULT OF HAVING THE PRODUCTS IMPLANTED, THE PATIENT HAS EXPERIENCED PAIN AND SWELLING; AND NORMAL DAILY ACTIVITIES WERE RESTRICTED DUE TO THE PAIN. THE PRIMARY SURGERY OCCURRED ON (B)(6) 2013 AND THE REVISION OCCURRED ON (B)(6) 2016. INTRAOPERATIVE FINDINGS DURING REPLACEMENT SURGERY WERE LOOSENING OF THE TIBIAL AND FEMORAL COMPONENTS WHICH RESULTED IN THE REVISION. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED AT THIS TIME, IF ADDITIONAL INFORMATION BECOMES AVAILABLE THE COMPLAINT WILL BE UPDATED ACCORDINGLY. INVOLVED COMPONENTS: NX033Z (PS FEMUR CEMENTED F6N RT), NX044 (UNIVERSAL PATELLA P4), NX055Z (PS TIBIA CEMENTED T3), NX132 (PS PE INSERT T3/T3+, 14MM), NN260P (PEEK PLUG F/ TIBIA). THE CEMENT USED WAS ZIMMER PALACOS R RADIOPAQUE BONE CEMENT. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER REFERENCE (B)(4). ASSOCIATED MEDWATCHES: 2916714-2020-00511, 2916714-2020-00512, 2916714-2020-00513, 2916714-2020-00514, 2916714-2020-00515.

  Patient problems: Ambulation or Postural Difficulties; Pain; Swelling/ Edema; Synovitis

  MAUDE report 11118508 ↗
• InjuryDec 8, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH A VEGA KNEE. THE PATIENT HAS EXPERIENCED PAIN AND SWELLING IN RIGHT KNEE, AND NORMAL DAILY ACTIVITIES WERE RESTRICTED DUE TO THIS PAIN. THE PRIMARY SURGERY OCCURRED ON (B)(6) 2012, AND THE REVISION SURGERY OCCURRED ON (B)(6) 2018. INTRAOPERATIVE FINDINGS DURING REPLACEMENT SURGERY WERE LOOSENING OF THE TIBIAL AND FEMORAL COMPONENTS, WHICH HAD RESULTED IN A REVISION SURGERY. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED AT THIS TIME, IF ADDITIONAL INFORMATION BECOMES AVAILABLE THE COMPLAINT WILL BE UPDATED ACCORDINGLY. INVOLVED COMPONENTS: NX031Z (PS FEMUR CEMENTED F5N RT). NX044 (UNIVERSAL PATELLA P4). NX055Z (PS TIBIA CEMENTED T3). NX130 (PS PE INSERT T3/T3+, 10MM). NN260P (PEEK PLUG F/ TIBIA). THE CEMENT USED WAS NOT SPECIFIED. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER REFERENCE (B)(4). ASSOCIATED MEDWATCHES: 2916714-2020-00631. 2916714-2020-00633. 2916714-2020-00634. 2916714-2020-00635.

  Patient problems: Ambulation or Postural Difficulties; Pain; Swelling/ Edema

  MAUDE report 10969855 ↗
• InjuryNov 9, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH KNEE COMPONENTS. AS A RESULT OF HAVING THE PRODUCT IMPLANTED THE PATIENT HAS EXPERIENCED UNKNOWN CLAIMS, BUT IT IS KNOWN THAT IT RESULTED IN A REVISION SURGERY. THE PRIMARY SURGERY OCCURRED ON (B)(6) 2016 AND THE REVISION SURGERY OCCURED ON (B)(6) 2017. CEMENT USED: ZIMMER PALACOS CEMENT. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED AT THIS TIME, IF ADDITIONAL INFORMATION BECOMES AVAILABLE THE COMPLAINT WILL BE UPDATED ACCORDINGLY. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER REFERENCE (B)(4). INVOLVED COMPONENTS: NO165Z (TIBIAL CEMENTED T4 LM). NO188Z (FEMUR CEMENTED F4 LM). NL473 (PE INSERT T4 RM/LM 7MM). NX044 (UNIVERSAL PATELLA P4). NP583R (THREADED PIN, HEADLESS 3.2MMX63MM). ASSOCIATED MEDWATCHES: 2916714-2020-00570. 2916714-2020-00571. 2916714-2020-00572. 2916714-2020-00574.

  Patient problems: Insufficient Information

  MAUDE report 10813374 ↗
• InjuryNov 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO AESCULAP INC. THAT AN VEGA KNEE IMPLANT SYSTEM, COMPRISED OF THE FOLLOWING COMPONENTS, VEGA SYSTEM PS TIBIA PLATEAU T3, CEMENTED IMPLANT (PART # NX055Z) (REF. ASSOCIATED MDR ID 2916714-2020-00526), VEGA SYSTEM PS FEMUR F6N L (PART #NX013Z) (REF. ASSOCIATED MDR ID 2916714-2020-00527), VEGA SYSTEM PEEK PLUG T1-T5 (PART # NN260P) (REF. ASSOCIATED MDR ID 2916714-2020-00528), PS+ GLIDING SURFACE IMPLANT 12MM T3/T3+ (PART # NX131) (REF. ASSOCIATED MDR ID 2916714-2020-00529), AND A PATELLA 3-PEG P2 (PART # NX044), WAS IMPLANTED DURING A PRIMARY SURGERY PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, FOLLOWING THE PRIMARY SURGERY, THE PATIENT EXPERIENCED KNEE PAIN, SWELLING, AND DIFFICULTY WALKING. THERE WAS NO REPORTED REVISION SURGERY. THE CEMENT USED DURING THE PRIMARY SURGERY IS UNKNOWN. THE COMPLAINT DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT HAS NOT BEEN MADE AVAILABLE. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4). INVOLVED COMPONENTS: NX055Z - AS VEGA PS TIBIAL PLATEAU CEMENTED T3 - LOT # 51904336. NX013Z - AS VEGA PS FEMORAL COMP. CEMENTED F6N L - LOT # 5

  Patient problems: Implant Pain; Swelling/ Edema

  MAUDE report 10804450 ↗
• InjuryOct 14, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH AS VEGA KNEE. IT WAS REPORTED THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PATIENT HAS EXPERIENCED KNEE PAIN, SWELLLING, DIFFICULTY WALKING, AND LOOSENING AND INSTABILITY OF THE DEVICE. THE PRIMARY PROCEDURE OCCURRED ON (B)(6) 2016, AND THERE WAS NO REVISION PERFORMED. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED AT THIS TIME, IF ADDITIONAL INFORMATION BECOMES AVAILABLE THE COMPLAINT WILL BE UPDATED ACCORDINGLY. INVOLVED COMPONENTS: NX009Z (PS FEMUR CEMENTED F4N LT). NX210 (PS PE INSERT T1/T1+, 10MM). NX052Z (PS TIBIA CEMENTED T1+). NN261Z (TIBIAL OBTURATOR D12MM, L7MM). NX043 (UNIVERSAL PATELLA P3). THE CEMENT USED IS BIOMET COBALT HV BONE CEMENT (402282). THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER REFERENCE (B)(4). ASSOCIATED MEDWATCHES: 2916714-2020-00417, 2916714-2020-00419, 2916714-2020-00420, 2916714-2020-00421.

  Patient problems: Ambulation or Postural Difficulties; Pain; Swelling/ Edema

  MAUDE report 10680316 ↗
• InjuryOct 8, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH A VEGA KNEE COMPONENTS. AS A RESULT OF HAVING THE PRODUCT IMPLANTED THE PATIENT HAS EXPERIENCED KNEE PAIN, SWELLING, DIFFICULTY WALKING, AND LOOSENING AND INSTABILITY OF THE IMPLANT. THE PRIMARY SURGERY OCCURRED ON (B)(6) 2013 AND THERE WAS NO REPORTED REVISION SURGERY. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED AT THIS TIME, IF ADDITIONAL INFORMATION BECOMES AVAILABLE THE COMPLAINT WILL BE UPDATED ACCORDINGLY. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER REFERENCE (B)(4). INVOLVED COMPONENTS: NX054Z (PS TIBIA CEMENTED T2+), NX044 (UNIVERSAL PATELLA P4), NX120 (PS PE INSERT T2/T2+, 10MM), NX011Z(PS FEMUR CEMENTED F5N LT), NN260P (PEEK PLUG F/TIBIA). ASSOCIATED MEDWATCHES: 2916714-2020-00460, 2916714-2020-00462, 2916714-2020-00463, 2916714-2020-00464.

  Patient problems: Ambulation or Postural Difficulties; Joint Laxity

  MAUDE report 10652583 ↗
• InjuryOct 6, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH AS VEGA KNEE. AS A RESULT OF HAVING THE PRODUCT IMPLANTED THE PATIENT HAS EXPERIENCED KNEE PAIN, SWELLING, DIFFICULTY WALKING, AND LOOSENING AND INSTABILITY OF THE IMPLANT. THE PRIMARY SURGERY OCCURRED ON (B)(6) 2012 AND THE REVISION SURGERY OCCURRED ON (B)(6) 2016. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THE COMPLAINT WILL BE UPDATED ACCORDINGLY. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER REFERENCE (B)(4). ASSOCIATED MEDWATCHES: 2916714-2020-00406. 2916714-2020-00407. 2916714-2020-00408. 2916714-2020-00410. INVOLVED COMPONENTS: NX011Z (PS FEMUR CEMENTED F5N LT). NN260P (PEEK PLUG F/ TIBIA). NX053Z (PS TIBIA CEMENTED T2). NX044 (UNIVERSAL PATELLA P4). NX120 (PS PE INSERT T2/T2+,10MM). THE CEMENT USED IS UNIDENTIFIED.

  Patient problems: Ambulation or Postural Difficulties; Joint Laxity

  MAUDE report 10635824 ↗